USITC to investigate Daewoong following Allergan complaint
The US International Trade Commission (ITC) has begun an investigation into Daewoong Pharmaceuticals of South Korea and California-based Evolus, following a complaint from Allergan.
In late January, Ireland-headquartered Allergan, which currently sells injectable Botox (onabotulinumtoxinA), filed its joint complaint with South Korean company Medytox. The ITC announced its investigation on Friday, March 1.
Medytox also makes BTX products and, through an exclusive licensing agreement, has partnered with Allergan to introduce MT10109L, a derivative of Medytox's Innotox, to the US market.
According to the claim, Daewoong has created Jeuveau, a botulinum neurotoxin (BTX), based on misappropriated trade secrets of Medytox.
One of Medytox’s former employees allegedly took confidential documents describing in
detail the company's “most secret, most protected manufacturing processes”, as well as a sample of Medytox's BTX strain, and went to work for Daewoong.
“Allergan's 30-year investment in the domestic BTX products market, including its partnership with Medytox, will be substantially injured by the unfair acts of respondents”, alleged the claim.
In September 2013, Daewoong entered into a licensing agreement with Evolus to import its BTX product into the US.
Allergan claimed: “During its short history, Evolus has hired a number of former Allergan employees and formed a management team around them, including its president and CEO, David Moatazedi, who was Allergan's senior vice president of US medical aesthetics.”
Since early 2014, Evolus has been engaged in the process of obtaining US Food and Drug Administration approval to market Jeuveau, with plans to launch the product in spring 2019. The product was approved in early February.
Allergan is concerned that Daewoong’s product will be marketed as a direct competitor to Botox, with the objective of “undercutting the domestic market” and obtaining a substantial market share.
“DWP-450 will directly compete with Botox and undercut Botox significantly on price, leading to lower revenue, lower profits, a reduced return on investment and, as a result, cause significant injury to the industry that Allergan has invested significantly to develop in the US,” argued the Irish company.
The complainants have asked the ITC to issue a limited exclusion order and cease-and-desist orders.
A spokesperson for Evolus said: “We remain confident in our IP and proprietary manufacturing process and will work with the ITC through its review.
“We continue to believe that Allergan and Medytox’s claims are completely without merit and that their complaint and associated timing reflect their level of concern surrounding Evolus’s entry as a new competitor that will enhance consumer and physician choice.”
Did you enjoy reading this story? Sign up to our free daily newsletters and get stories sent like this straight to your inbox.
